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RSS FeedPosted by Michael Wonder on 31 Jul 2020
Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine
31 July 2020 - Both companies are committed to making their COVID-19 vaccine affordable and available globally. ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 real-world evidence and observational studies
31 July 2020 - Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main ...
Posted by Michael Wonder on 27 Jul 2020
EU talks with Pfizer, Sanofi, J&J on COVID vaccines hit snags
28 July 2020 - European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson are mired in ...
Posted by Michael Wonder on 22 Jul 2020
First Covid-19 vaccine may be approved in 2020, EU regulator says
21 July 2020 - EMA will start rolling review of data, production after summer. ...
Posted by Michael Wonder on 19 Jul 2020
Drug regulators remain united on COVID-19, says EU agency boss
18 July 2020 - The fight among governments to secure treatments has brought regulators closer together, says Guido Rasi. ...
Posted by Michael Wonder on 09 Jul 2020
International regulators align positions on phase 3 COVID-19 vaccine trials
9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...
Posted by Michael Wonder on 05 Jul 2020
Oxford University is leading in the vaccine race
2 July 2020 - Governments are pouring money into a more urgent version of the space race. ...
Posted by Michael Wonder on 02 Jul 2020
Johnson & Johnson announces European Commission approval for Janssen’s preventive Ebola vaccine
1 July 2020 - This marks the first major regulatory approval of a vaccine developed by Janssen. ...
Posted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 18 Jun 2020
International regulators stress value of safe and effective vaccines
18 June 2020 - EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the ...
Posted by Michael Wonder on 09 Jun 2020
First adjuvanted quadrivalent influenza vaccine by Seqirus receives EU approval
8 June 2020 - The European Commission has today given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become ...
Posted by Michael Wonder on 31 May 2020
Johnson & Johnson receives positive CHMP opinion for Janssen’s investigational preventive Ebola vaccine regimen
29 May 2020 - The investigational Ebola vaccine regimen leverages Janssen’s established AdVac and PER.C6 technologies and Bavarian Nordic’s MVA-BN technology. ...
Posted by Michael Wonder on 31 May 2020
Highlights from the May 25-28 CHMP meeting
29 May 2020 - Eight new medicines recommended for approval. ...
Posted by Michael Wonder on 27 May 2020
EMA publishes agenda for 25-28 May 2020 CHMP meeting
27 May 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 27 May 2020
EMA commissions independent research to prepare for real world monitoring of COVID-19 vaccines
27 May 2020 - EMA is engaging early with researchers to ensure that a European infrastructure will be in place to ...